Clinical Trials

Current Projects

A Community based interventions to improve HIV outcomes in young people: A cluster randomised trial in Zimbabwe: (CHIEDZA)

Principal Investigator: Professor Rashida

CHIEDZA is a cluster randomised trial which is Community based interventions to improve the HIV outcomes in young people. Adolescents and Young People (AYP) fare disproportionately poorly across the HIV care continuum compared to other age-groups: the prevalence of undiagnosed HIV is substantially higher, and coverage of and adherence to ART is lower, resulting overall in worse virological outcomes.


Principal Investigator: Prof Rashida Ferrand

In order to study the effect of providing vitamin D3 and calcium for children who have HIV, we will recruit 840 children, who meet the recruitment criteria, at Harare Children’s Hospital in Harare, Zimbabwe and at the University Teaching Hospital in Lusaka, Zambia. For the children and adolescents who are potentially eligible, our clinical team will approach and inform their caregivers about the study. If both caregivers and children/adolescents themselves provide written consent and assent, they will either be given a daily supplementation of calcium (500mg) and a weekly high-dose of vitamin D3 (20,000IU) or a placebo, both for 48 weeks.

Bronchopulmonary function in response to azithromycin treatment for chronic lung disease in HIV-infected children (BREATHE) study

Principal Investigator: Professor Rashida

BREATHE is a multi-site, individually randomised, double-blinded, placebo-controlled clinical trial. The trial aims to assess whether adjuvant treatment with azithromycin results in improvement in lung function in HIV-positive children with chronic lung disease. The main study outcome is Forced Expiratory Volume in one second z- score (FEV1z) after 12 months of initiation of the trial drug. 

Feasibility and acceptability of HIV self-testing in adolescents and young people (FAST) study

Principal Investigator: Dr. Grace McHugh

Funder :European and Developing Countries Clinical Trial Partnership (EDCTP)

Youth have the highest incidence of HIV in sub-Saharan Africa but the lowest rates of testing. The feasibility and acceptability of HIV self-testing in adolescents and young people (FAST) study will investigate whether self-testing using oral mucosal transudate tests could be a solution. Participants will have the option of downloading a mobile app, ITHAKA, which gives step by step instructions on how to test. We will distribute 5000 self-testing kits to youth aged 16-24 at tertiary education institutions and community centres, over 12 months and measure the proportion of people who complete a test and, if necessary, are linked to care. 

Community based viral load Differentiated care in Rural Africa (CBART)

Principal Investigator: Professor David Katzenstein

The project is an open label randomized trial among HIV infected children and adolescents  receiving ART at 8 treatment outreach sites near their homes provided by Chidamoyo Mission Hospital. We will implement VL testing at “near point of care” using the GeneXpert Quant to evaluate the safety, clinical and virologic outcomes of near POC monitoring of virus load at the  Chidamoyo Christian Hospital in Mashonaland West Zimbabwe. 600 subjects are randomized 1:1 to receive Standard of care (SOC) VL or near point-of-care (nPOC) VL every 6 months with confirmatory testing  of VL  > 1,000 copies/ml and drug switching. Lower cost genotyping will be provided on confirmed Virologic failure samples as requested by providers.

Past Projects

Study for enhancing testing and improving treatment of HIV in children (ZENITH project)

To investigate whether a package of services at primary care level will adequately meet the needs of vertically HIV-infected children and adolescents, or alternatively whether further decentralisation to provide community-level HIV testing and/or treatment support is required.